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| Product Name | Clinical Chemistry Analyzer Sample Diluent, Surfactant-Free |
| Catalog No. | ATRD-0026 |
| Description | Surfactant-free sample diluent specifically formulated for automated clinical chemistry analyzers to dilute patient serum, plasma, and urine samples exceeding the linear range of photometric and turbidimetric assays. The surfactant-free composition eliminates bubble formation in cuvette flow cells and prevents interference with lipase, amylase, and other enzyme activity measurements that can be artificially elevated by surfactant activation. Isotonic saline base with antimicrobial preservative maintains sample integrity during automated rerun protocols and long sample queues on high-throughput analyzers. |
| Intended Use | Automated dilution of clinical serum, plasma, and urine samples on random-access chemistry analyzers when analyte concentrations exceed assay linear range, enabling accurate reportable results without manual off-line dilution steps. |
| Principle / Technology | Isotonic dilution maintains sample matrix consistency; surfactant-free formula avoids interference with enzyme kinetics and bubble formation; preservative prevents bacterial growth in open reagent bottles on analyzer decks. |
| Detection Method | Program analyzer dilution protocol at 1:2 to 1:100 ratio depending on analyte and analyzer linear range; verify dilution linearity with quality control materials at expected dilution factors. |
| Sample Type | Human serum, lithium heparin plasma, EDTA plasma, random urine specimens. |
| Performance Range / Specifications | Dilution linearity R² >0.995 across 1:2 to 1:100 dilution range for spectrophotometric and turbidimetric clinical chemistry assays. |
| Sensitivity / LOD | Carryover <0.01% as measured by alternating high and low concentration samples; surfactant-free means no interference with lipase, amylase, or GGT activity assays. |
| Specificity | Surfactant-free and enzyme-inert composition avoids false elevation of pancreatic enzyme activities and bubble-related optical artifacts in absorbance-based detection systems. |
| Reaction Conditions / Protocol | Sample automatically diluted by analyzer according to programmed dilution protocol; no manual sample preparation required. |
| Components / Formulation | Sodium chloride 0.9% w/v, ProClin 300 preservative 0.05% v/v, deionized water. |
| Storage Conditions | Store at 2-25 °C in original container; avoid contamination; replace bottle according to analyzer manufacturer on-board stability guidelines. |
| Shelf Life | 24 months from date of manufacture in unopened container; 30 days on-board stability on analyzer. |
| Package Specifications | 2 × 50 mL analyzer-compatible bottles; 6 × 50 mL multi-pack for high-volume laboratories. |
| Product Form | Clear, colorless liquid; filtered 0.2 µm. |
| Quality Control | Each lot tested for osmolality, pH, microbial bioburden, and absence of interfering enzymatic activity in a panel of 10 routine clinical chemistry assays. |
| Key Features | Surfactant-free for enzyme assay compatibility; isotonic for sample integrity; bubble-free flow characteristics; long on-board stability; compatible with major analyzer platforms including Roche, Abbott, Siemens, and Beckman Coulter systems. |
| Purity | Sodium chloride USP grade ≥99.5%; water for injection quality; endotoxin <0.05 EU/mL. |
| Concentration | Ready-to-use 1× formulation. |
| Activity / Unit Definition | N/A — diluent serves as sample matrix extender without enzymatic or biological activity. |
| Molecular Weight | Sodium chloride: 58.44 g/mol. |
| Source / Origin | Pharmaceutical grade sodium chloride; USP purified water. |
| pH Range / Optimal pH | pH 6.5-7.5 at 25 °C. |
| Shipping Conditions | Ambient temperature. |
| Expiration Date / Stability | 24 months unopened; 30-day on-board stability once opened and placed on analyzer; discard if visible turbidity develops. |
| Regulatory / Compliance | For in vitro diagnostic use as an accessory reagent; manufactured under ISO 13485 quality management system. CE-marked where applicable. |
| Compatibility | Compatible with Roche Cobas c-series, Abbott Architect c-series, Siemens Atellica and ADVIA Chemistry, Beckman Coulter AU and DxC analyzer systems. Verify compatibility with each assay parameter per laboratory validation protocol. |
| Recommended Buffer System | Unbuffered isotonic saline; pH adjustment with NaOH/HCl as needed. |
| Application Notes / Precautions | Verify dilution recovery for each analyte per CLSI EP34 guidelines before implementing automated dilution protocols. Run diluted QC materials at expected dilution factors to confirm dilution linearity. Replace bottle immediately if preservative odor weakens or turbidity develops, indicating microbial growth. Do not dilute samples for electrolyte (ISE) measurements — use separate diluent if required by analyzer. |
| Batch-to-Batch Consistency | Osmolarity within ±5 mOsm/kg; pH within ±0.2 units; preservative concentration within ±10% of specification. |
For research use only, not for clinical use.
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